Emotion Regulation During RCT of CBT vs. MBSR for Social Anxiety Disorder

Social Anxiety Disorder Clinical Trial

Official title:

fMRI of Emotion Regulation During RCT of CBT vs. MBSR for Social Anxiety Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02036658
• Other study ID #: CBT-MBSR 10521038
• Secondary ID: R01MH076074
• Status: Completed
• Phase: N/A
• First received: January 10, 2014
• Last updated: January 16, 2018
• Start date: March 2011
• Est. completion date: September 1, 2015

Study information

• Verified date: January 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to investigate the immediate and longer-term impact of Cognitive-Behavioral Group Therapy (CBGT) versus Mindfulness-Based Stress Reduction (MBSR) for patients with Social Anxiety Disorder.

Description:

A. Aims

The overall goal of this research is to elucidate the neural bases of two specific forms of emotion regulation - cognitive regulation (CR) and attention regulation (AR). CR and AR are thought to be important mechanisms underlying therapeutic change associated with Cognitive-Behavioral Therapy (CBT) and Mindfulness-Based Stress Reduction (MBSR) for generalized Social Anxiety Disorder (SAD). We seek to test whether changes in CR and AR underlie the therapeutic effects of CBT and MBSR, which have been shown in the clinical science literature to be effective treatments for SAD. We will examine CR and AR in healthy controls (HCs) and in participants with generalized SAD at baseline, as well as in participants with SAD after they have completed a randomized controlled trial (RCT) with three treatment arms: CBT, MBSR, or Waitlist (WL). This work will address 3 aims: Aim 1 will examine the efficacy of CR and AR in individuals with SAD versus HCs; Aim 2 will investigate the immediate and longer-term impact of CBT versus MBSR for SAD; and Aim 3 will examine treatment-related changes in CR and AR and test whether these changes mediate the effects of CBT versus MBSR. The broad, long-term objective of this research is to contribute to advances in clinical interventions targeting individuals suffering from SAD, as well as a wide range of other anxiety and mood disorders.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: September 1, 2015
• Est. primary completion date: September 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

Inclusion Criteria:

• Clinically diagnosable social anxiety disorder (generalized subtype per DSM-IV-TR criteria)

• aged 21-55

• working fluency in English

• residence in the Bay Area.

• eligible for fMRI scans (right-handed, no metal in body, etc.)

Exclusion Criteria:

• left-handed

• Medication use in the last 3 months

• Pervasive developmental disability

• acute suicide potential

• inability to travel to the treatment site

• schizophrenia or other psychotic disorder

• history of bipolar disorder

• current primary Major Depression

• current substance dependence

• Comorbid diagnoses of Major Depressive or other mood or anxiety disorders are acceptable ONLY if clearly secondary to the diagnosis of social anxiety disorder.

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Phobia, Social
• Social Anxiety Disorder

Intervention

Behavioral:
• Cognitive Behavioral Group Therapy
Cognitive Behavioral Group Therapy for social anxiety disorder is a 12-week treatment that involves psychoeducation, cognitive restructuring and exposure to social situations.
• Mindfulness-Based Stress Reduction
Mindfulness-Based Stress Reduction will be completed in 12 weeks in the study and includes enhancing one's awareness non-judgmentally by focusing on the present moment through the use of mindfulness meditation.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (8)

American Psychiatric Association. Diagnostic and statistical manual, 4th edn, Text Revision (DSM-IV-TR). American Psychiatric Association, Washington. 2000.

Goldin PR, Morrison A, Jazaieri H, Brozovich F, Heimberg R, Gross JJ. Group CBT versus MBSR for social anxiety disorder: A randomized controlled trial. J Consult Clin Psychol. 2016 May;84(5):427-37. doi: 10.1037/ccp0000092. Epub 2016 Mar 7. — View Citation

Goldin PR, Morrison AS, Jazaieri H, Heimberg RG, Gross JJ. Trajectories of social anxiety, cognitive reappraisal, and mindfulness during an RCT of CBGT versus MBSR for social anxiety disorder. Behav Res Ther. 2017 Oct;97:1-13. doi: 10.1016/j.brat.2017.06. — View Citation

Heimberg RG, Becker RE. Cognitive-behavioral group therapy for social phobia: Basic mechanisms and clinical strategies. Guilford Press; 2002.

Hope DA, Heimberg RG, Turk CL. Managing social anxiety: A cognitive-behavioral therapy approach. Treatments That Work; 2010.

Kabat-Zinn J. Mindfulness meditation: Health benefits of an ancient Buddhist practice. In D. Goleman & J. Gurin (Eds.), Mind/Body Medicine (pp. 259-275). Yonkers, NY: Consumer Reports Books, 1993.

Liebowitz MR. Social phobia. Mod Probl Pharmacopsychiatry. 1987;22:141-73. — View Citation

Stahl B, Goldstein E. A mindfulness-based stress reduction workbook. New Harbinger Publications; 2010 Mar 1.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Liebowitz Social Anxiety Scale (LSAS)	The Liebowitz Social Anxiety Scale (LSAS) is a self-report questionnaire which assesses the severity of social anxiety symptoms (Fresco et al., 2001; Liebowitz, 1987). Respondents are asked to rate their level of fear and avoidance to 11 social interaction situations and 13 performance situations. A 4-point Likert-type scale is used for ratings of fear and of avoidance, with a range from 0 (none and never, respectively) to 3 (severe and usually, respectively) for each situation during the past week. Ratings are summed for a total LSAS-SR score (range 0 to 144). The LSAS-SR has demonstrated good reliability and construct validity (Rytwinski et al., 2009).	from baseline to 1- year following treatment